New Genomic Techniques and unintended genetic changes: EFSA ‘overlooked’ most of the scientific findings

The Food Authority did not have a mandate to systematically search and analyse the relevant scientific publications

12. December 2022

12 December 2022 / Testbiotech will today be participating in a panel discussion organised by the European Food Safety Authoriy (EFSA) about new criteria for risk assessment of plants derived from new genomic techniques (NGTs or also New GE). In a document, recently published, EFSA has created the impression that there is, in most cases, no need to take the unintended genetic changes caused by NGT processes into account. EFSA appears to assume that the unintended genetic changes and the associated risks could not be distinguished from those resulting from conventional breeding. Consequently, the approach as suggested by EFSA would mean a substantial reduction in current standards of risk assessment.

It looks like the EFSA assumptions largely originate from inadequate data: in the context of its previous opinions, the authority has stated several times that it did not have a mandate to comprehensively assess all relevant scientific publications. On the contrary, it seems that EFSA has, in fact, simply ‘overlooked’ most of the relevant publications.

Indeed, many publications show that the multi-step processes of NGTs are associated with intended and unintended genetic changes that can be different to those resulting from conventional breeding methods. This is especially relevant for organisms engineered with ‘gene scissors’ such as CRISPR/Cas. Such differences between conventional breeding and NGTs can be easily overlooked, but can, nevertheless, have serious consequences: if overlooked, hazardous genetic changes can rapidly spread throughout large populations.

Unintended genetic changes caused by NGT processes that are unlikely to result from conventional breeding are highly relevant to the risk assessment of NGT organisms. The reason: these changes may trigger risks that were not anticipated and which may go beyond what is known from conventional breeding.

As shown in the backgrounder published today, EFSA only mentions around 20 percent of the relevant publications forwarded by Testbiotech during the public consultation process. Similarly, several publications provided by experts from EU Member States were not taken into account. Furthermore, even if publications were listed in the EFSA references, none of these were addressed in the reports in order to systematically examine unintended effects caused by NGT procedures.

Consequently, the criteria proposed by EFSA for the risk assessment of NGT plants are not sufficiently science-based. Testbiotech is, therefore, demanding that EFSA withdraws its proposal (‘statement’) for the future risk assessment of plants derived from new genome techniques (NGT).

Christoph Then, Tel + 49 (0)151 54638040,

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